Laser, Ophthalmic
Product Code: HQF
Ophthalmic Medical Laser Products
Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]
Code of Federal Regulations: 886.4390
| Radiation Type | Optical |
| Radition Safety | Product |
| Annual Reports | Yes |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm And 577 Nm Models) | Iridex Corporation |
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | Ellex Medical Pty Ltd |
| K222157 | ECHO Photocoagulator | Norlase |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Be, Inc. |
| K220430 | Capsulo | Quantel Medical |
| K213592 | Iridex 810 Laser | Iridex Corporation |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | Ellex Medical Pty Ltd |
| K202760 | Iridex 810 Laser | Iridex Corporation |
| K201502 | Vitra 810 | Quantel Medical |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. |
| K190448 | LightLas Pattern Scanning System - TruScan Pro | Light-Med(USA), INC. |
| K190083 | Leaf Photocoagulator | Norlase ApS |
| K181682 | VISULAS Green | Carl Zeiss Meditec AG |
| K180402 | PSLT With PASCAL Synthesis, PSLT With PASCAL Synthesis TwinStar | Topcon Medical Laser Systems, Inc. |
| K171488 | PSLT For PASCAL Streamline | Topcon Medical Laser Systems, Inc. |
| ZIEMER FEMTO LDV | SIE AG, SURGICAL INSTRUMENT ENGINEERING | 2020-03-25 |
| ZIEMER FEMTO LDV | SIE AG, SURGICAL INSTRUMENT ENGINEERING | 2020-03-25 |
| ZIEMER FEMTO LDV | SIE AG, SURGICAL INSTRUMENT ENGINEERING | 2020-03-25 |
| | 2020-03-23 |
| TANGO R | ELLEX MEDICAL PTY LTD | 2020-03-13 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-03-10 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-03-10 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-03-10 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-03-03 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-03-03 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-03-03 |
| DIRECTIONAL LASER PROBE WITH DORC CONNECTOR (25 GAUGE / 0.5 MM) | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA | 2020-03-03 |
| VISULAS GREEN | CARL ZEISS MEDITEC AG (JENA) | 2020-03-02 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-03-02 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-02-27 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-02-21 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-02-11 |
| TANGO | ELLEX MEDICAL PTY LTD | 2020-01-30 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-01-16 |
| FEMTO | SIE AG, SURGICAL INSTRUMENT ENGINEERING | 2020-01-16 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-01-13 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2020-01-03 |
| EVAPHACOEMULSIFICATION/VITRECTOMY SYSTEM | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA | 2019-11-22 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-10-17 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-10-14 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-10-07 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-10-07 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-09-24 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-09-19 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-09-16 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-09-16 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-09-13 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-09-10 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-09-03 |
| TANGO REFLEX | ELLEX MEDICAL PTY LTD | 2019-09-03 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-08-27 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-08-20 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-08-13 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-07-24 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-07-23 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-07-16 |
| ULTRA Q REFLEX | ELLEX MEDICAL PTY LTD | 2019-07-03 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-06-19 |
| 25G FLEXIBLE TIP LASER PROBE | ALCON RESEARCH, LLC (FORMERLY KNOWN AS ALCON RESEARCH LTD.) | 2019-06-17 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-06-17 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-06-11 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-06-04 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-05-30 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-05-29 |
| PUREPOINT LASER | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | 2019-05-23 |